Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE Study)

To assess the safety and effectiveness of the Shockwave Medical SkyRunner Carotid IVL System for the treatment of calcified carotid arteries prior to stenting with commercially available trans-femoral stent systems in patients at high risk for complications from carotid endarterectomy (CEA). Up to 160 subjects at up to 25 sites in the United States (US) in the primary analysis cohort. Additionally, one roll-in subject must be enrolled per site for up to 25 roll-in subjects. These roll-in subjects will not count toward the up to 160 subject target enrollment for the primary analysis cohort. The…